Comparison of vascular findings between symptomatic and asymptomatic postmenopausal women before and during hormone therapy: randomized, placebo-controlled prospective study
- Conditions
- Healthy postmenopausal women willing to initiate hormone therapy.
- Registration Number
- EUCTR2004-005091-16-FI
- Lead Sponsor
- Helsinki University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 160
Inclusion Criteria
Healthy postmenopausal women between ages 48-55 (minimum of 6 months and maximum of 36 months from last menstrual period) that are willing to start HT for the treatment of vasomotor symptoms, other climacteric symptoms such as vaginal atrophy or prevention of osteoporosis. FSH over 30 U/L.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Dyslipidemia, diabetes or overt hypertension (blood pressure > 140/90) are excluding criteria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: In a randomized clinical trial compare recently menopausal women with or without vasomotor symptoms on response to HT as measured by several different biological markers;Secondary Objective: ;Primary end point(s): Pulse Wave analysis
- Secondary Outcome Measures
Name Time Method